CEDIA OPIATE APPLICATION BECKMAN COULTER AU5800

Transcription

1 CEDIA OPIATE APPLICATION BECKMAN COULTER AU5800 Catalog No , , Intended for the qualitative and semiquantitative determination of opiates in human urine For In Vitro Diagnostic and Rx Use Microgenics Corporation Intended Use The information provided in this application sheet is intended as a supplement to the package insert. Refer to the package insert for information on intended use, reagent storage, reagent preparation, specimen collection, specimen preparation, specimen storage, quality control, and additional performance data. Ordering Information Item Size Catalog No. CEDIA Opiate Assay 3 x17 ml 65 ml 495 ml CEDIA Multi Drug Negative Calibrator 5 ml ml CEDIA Multi Drug Secondary Calibrator 5 ml ml CEDIA Multi Drug Intermediate Calibrator 5 ml ml CEDIA Multi Drug High Calibrator 5 ml 15 ml MGC Clinical DAU Control Set 3 x 5 ml To place an order or for technical service, contact: USA Tel: (800) Fax: (510) In Europe Tel: +49 (0) Fax: +49 (0) Microgenics Corporation, part of Thermo Fisher Scientific Kato Road, Fremont, CA USA U.S. Toll free: (800) / Tel: (510) U.S. Toll free fax: (888) / Fax: (510) EC REP Thermo Fisher Scientific Oy Ratastie 2, P.O. Box 100, Vantaa, Finland Tel: / Fax: Continued on next page Page 1 of APS, Rev. 2

2 Reagent Storage Refer to the package insert for information on reagent storage. Procedure for Analyzer Refer to the operator s manuals for information on analyzer operation. Dispense adequate amounts of Reagents 1 (EA Reagent) and Reagent 2 (ED Reagent) into appropriate containers. Ensure that reagents have equilibrated to the temperature of the analyzer reagent compartment before starting analysis. Results and Data Interpretation Refer to the package insert for information on results and data interpretation. Page 2 of APS, Rev. 2

3 Beckman Coulter AU5800 CEDIA Opiate, Qualitative Specific Test General LIH ISE HbA1c Calculated Test Range Test Name: PCP-Q < > Type: Urine Operation Yes Sample Volume 2 µl Dilution 0 µl OD Limit Pre-Dilution Rate 1 Diluent Bottle # Min.OD Max.OD 3.00 Rgt. Volume R1(R1-1) 87 µl Dilution 0 µl Reagent OD Limit R1-2 µl Dilution µl 1 st. Low High 3.00 Last Low High 3.00 R2(R2-1) 87 µl Dilution 0 µl Dynamic Range Low # High # Common Rgt. Type None Name None Correlation Factor A 1 B Wavelength Pri 570 nm Sec. 660 nm Factor for Maker A 1 B 0 Method FIXED Reaction Slope + Onboard Stability Period 60 Day # Hour Measuring Point1 1 st 24 Last 27 LIH Influence Check # Measuring Point2 1 st Last Lipemia Linearity Limit % Icterus Lag Time Check No Hemolysis Specific Test General LIH ISE HbA1c Calculated Tests Range Test Name # < > Type Urine Value/Flag # Level Low High Specific Ranges: From To Sex Year Month Year Month Low High 1 # # # # # # # 2 # # # # # # # 3 # # # # # # # 4 # # # # # # # 5 # # # # # # # 6 # # # # # # # 7 Standard Demographics # # 8 Not within expected values # # Panic Value Low # High # Unit % Decimal Places # # User defined Option 1: Enter 0.0 Option 2: Enter 0.0 Option 3: Enter -100 Option 1: Enter Option 2: Enter 100 Option 3: Enter 0.0 Option 1: Run a reagent blank (blue rack). Run the cutoff calibrator in a white rack. Compare the sample response to the cutoff calibrator response to determine if the sample is positive or negative. Positive samples will not be flagged. Option 2: Run a reagent blank (blue rack). Calibrate by placing the appropriate cutoff calibrator in the assigned position in the calibration rack (yellow rack). Positive samples will be flagged (P) and will be greater than or equal to 100. Option 3: Run a reagent blank (blue rack). Calibrate by placing the appropriate cutoff calibrator in the assigned position in the calibration rack (yellow rack). Positive samples will be flagged (P) and will be greater than or equal to zero. Page 3 of APS, Rev. 2

4 Beckman Coulter AU5800 CEDIA Opiate, Qualitative (continued) (Option 1) Calibration Calibrators Calibration Specific STAT Table Calibration Microgenics Corporation Test Name # < > Type Urine Use Serum Cal. Calibration Type MB Formula Y=AX+B Counts 2 < Calibrator > Range Slope Check Calibrator OD Conc Low High Point-1 Allowable Range Check Point-2 Reagent Blank Point-3 Calibration Point-4 Point-5 Advanced Calibration Point-6 Operation No Point-7 Interval (RB/ACAL) Point-8 Point-9 Lot Calibration Point-10 < Point Cal. For Master Curve > No. of Correction Points Use Master Curve OD Range Calibrator OD Conc Low High Stability Point-1 Reagent Blank Day Hour Point-2 Calibration Day Hour MB Type Factor Point Calibration Point with Conc-0 (Option 2 or 3) Calibration Calibrators Calibration Specific STAT Table Calibration Test Name # < > Type Urine Use Serum Cal. Calibration Type AB Formula Y=AX+B Counts 2 < Calibrator > Factor Range Slope Check + Calibrator OD Conc Low High Point-1 # Allowable Range Check Point-2 Reagent Blank Point-3 Calibration Point-4 Point-5 Advanced Calibration Point-6 Operation No Point-7 Interval (RB/ACAL) Point-8 Point-9 Lot Calibration Point-10 < Point Cal. For Master Curve > No. of Correction Points Use Master Curve OD Range Calibrator OD Conc Low High Stability Point-1 Reagent Blank # Day # Hour Point-2 Calibration # Day # Hour MB Type Factor 1-Point Calibration Point None with Conc-0 # User defined Page 4 of APS, Rev. 2

5 Beckman Coulter AU5800 CEDIA Opiate, Semiquantitative Specific Test General LIH ISE HbA1c Calculated Test Range Test Name: PCP-Q < > Type: Urine Operation Yes Sample Volume 2 µl Dilution 0 µl OD Limit Pre-Dilution Rate 1 Diluent Bottle # Min.OD Max.OD 3.00 Rgt. Volume R1(R1-1) 87 µl Dilution 0 µl Reagent OD Limit R1-2 µl Dilution µl 1 st. Low High 3.00 Last Low High 3.00 R2(R2-1) 87 µl Dilution 0 µl Dynamic Range Low # High # Common Rgt. Type None Name None Correlation Factor A 1 B 0 Wavelength Pri 570 nm Sec. 660 nm Factor for Maker A 1 B 0 Method FIXED1 Reaction Slope + Onboard Stability Period 60 Day # Hour Measuring Point1 1 st 24 Last 27 LIH Influence Check # Measuring Point2 1 st Last Lipemia Linearity Limit % Icterus Lag Time Check No Hemolysis Specific Test General LIH ISE HbA1c Calculated Tests Range Test Name # < > Type Urine Value/Flag # Level Low High # # Specific Ranges: From To Sex Year Month Year Month Low High 1 # # # # # # # 2 # # # # # # # 3 # # # # # # # 4 # # # # # # # 5 # # # # # # # 6 # # # # # # # 7 Standard Demographics # # 8 Not within expected values # # Panic Value Low # High # Unit ng/ml Decimal Places # Page 5 of APS, Rev. 2

6 Beckman Coulter AU5800 CEDIA Opiate, Semiquantitative (continued) Calibration Calibrators Calibration Specific STAT Table Calibration Test Name # < > Type Urine Use Serum Cal. Calibration Type 4AB Formula POLYGONAL Counts 2 < Calibrator > Range Slope Check + Calibrator OD Conc Low High Point-1 # Allowable Range Check Point-2 # Reagent Blank Point-3 # Calibration Point-4 # Point-5 Advanced Calibration Point-6 Operation No Point-7 Interval (RB/ACAL) Point-8 Point-9 Lot Calibration Point-10 < Point Cal. For Master Curve > No. of Correction Points Use Master Curve OD Range Calibrator OD Conc Low High Stability Point-1 Reagent Blank # Day # Hour Point-2 Calibration # Day # Hour MB Type Factor 1-Point Calibration Point None with Conc Thermo Fisher Scientific Inc. All rights reserved. All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified. CEDIA is a trademark of Roche Diagnostics. AU Series Systems are trademarks of Beckman Coulter. End Page 6 of APS, Rev. 2